The impact of integrating food supplementation, nutritional education and HAART (Highly Active Antiretroviral Therapy) on the nutritional status of patients living with HIV/AIDS in Mozambique: result from the DREAM programme

DREAM (Drug Resources Enhancement against AIDS and Malnutrition) is a multiregional health program active in Mozambique since 2002 and provides free of charge an integrating package of care consisting of peer to peer nutritional and health education, food supplementation, voluntary counseling and testing, immunological, virological, clinical assessment and HAART (Highly Active AntiRetroviral Treatment). The main goals of this paper are to describe the state of health and nutrition and the adequacy of the diet of a sample of HIV/AIDS patients in Mozambique on HAART and not. A single-arm retrospective cohort study was conducted. 106 HIV/AIDS adult patients (84 in HAART), all receiving food supplementation and peer-to-peer nutritional education, were randomly recruited in Mozambique in two public health centres where DREAM is running. The programme is characterized by: provision of HAART, clinical and laboratory monitoring, peer to peer health and nutritional education and food supplementation. We measured BMI, haemoglobin, viral load, CD4 count at baseline (T0) and after at least 1 year (T1). Dietary intake was estimated using 24h food recall and dietary diversity was assessed by using the Dietary Diversity Score (DDS) at T1. Overall, the patients'diet appeared to be quite balanced in nutrients. In the cohort not in HAART the mean BMI values showed an increases but not significant (initial value: 21.9±2.9; final value: 22.5±3.3 ) and the mean haemoglobin values (g/dl) showed a significant increases (initial value: 10.5+ 2.1; final value: 11.5±1.7 p< 0.024) . In the cohort in HAART, both the mean of BMI value (initial value: 20.7±3.9; final value: 21.9±3.3 p< 0.001) and of haemoglobin (initial value: 9.9±2.2; final value: 10.8±1.7 p< 0.001) showed a higher significant increase. The increase in BMI was statistically associated with the DDS in HAART patients. In conclusion nutritional status improvement was observed in both cohorts. The improvement in BMI was significant and substantially higher in HAART patients because of the impact of HAART on nutritional status of AIDS patients. Subjects on HAART and with a DDS > 5, showed a substantial BMI gain. This association showed an additional expression of the synergic effect of integrating food supplementation, nutritional education and HAART on the nutritional status of African AIDS patients and also highlights the complementary role of an adequate and diversified diet in persons living with HIV/AIDS in resources limited settings

Cost-Effectiveness of Using HAART in Prevention of Mother-To-Child Transmission in the DREAM-Project Malawi

Introduction: Cost-effectiveness analysis are crucial in the management of the HIV/AIDS epidemic, particularly in resource-limited settings. Such analyses have not been performed in the use of highly active antiretroviral therapy (HAART) for prevention of mother-to-child transmission (PMTCT). Objective: Cost-effectiveness analysis of HAART approach in Malawi for PMTCT. Methods: In 2 health centres in Malawi 6500 pregnant women were tested; 1118 pregnant women completed the entire Drug Resource Enhancement against Aids and Malnutrition-Project Malawi (DREAM - PM) PMTCT protocol. The costs of the intervention were calculated using the ingredients method. Outcomes estimated were cost for infection averted and cost for DALY saved compared with no intervention. Results: From a private perspective cost for HIV infection averted was US $998 and cost per DALY saved was US$35.36. From a public perspective, the result became negative as follows: −261 and −16.55, respectively (lower cost than the cost of the therapy for an HIV+ child). The univariate sensitivity analysis showed that the cost for DALY saved always remained under the threshold of US $50, largely under the threshold given by the per capita yearly income in Malawi (US$667 PPD). Conclusions: Administration of HAART in a PMTCT programme in resource-limited settings is cost-effective. Drugs and laboratory tests are the most significant costs, but further reduction of these expenses is possible

Extended antenatal antiretroviral use correlates with improved infant outcomes throughout the first year of life

OBJECTIVES: To evaluate the effect of extended antenatal triple antiretroviral therapy (ART) on infant outcomes. DESIGN: Retrospective cohort study using pooled data from health clinics in Malawi and Mozambique from July 2005 to December 2009. METHODS: Computerized records of 3273 HIV-infected pregnant women accessing Drug Resource Enhancement Against AIDS and Malnutrition centers were reviewed. ART regimens consisted of nevirapine-based HAART as of 14-25 weeks gestation until 6 months postpartum. Infant infection was determined at 1, 6 and 12 months of age by branched DNA. RESULTS: A total of 3071 pregnancies resulted in 3148 live births. Lost to follow-up, infant deaths and HIV-1 infection rates at 1 and 12 months were 1.3 and 11.5, 0.8 and 6.7 and 0.8 and 2.0, respectively. Infant HIV-1-free survival at 12 months was 92.5%. Mother-to-child transmission and/or infant deaths correlated with length of maternal antenatal ART by multivariate analysis at 1, 6 and 12 months: 14% in women with more than 30 days of triple antenatal ART and 6.9% in mothers receiving at least 90 days of antenatal ART, P = 0.001. Fifty percent of 54 episodes of transmission occurred in women with higher CD4 cell counts (>350 cells/μl). Infant mortality was 67/1000, lower than background rates (78-100/1000). Growth failure (weight-for-age Z score <-2) was present in 8% of infants around birth, 6% at 6 months, 23% at 12 months (lower than country-specific rates). CONCLUSION: Extended antenatal ART is protective against adverse infant outcomes up to 12 months of age even in children born to mothers with higher CD4 cell counts. PMID: 2088528

HAART as a Strategy for Reduction of HIV-1 Transmission in Sub-Saharan Africa: Survival and Virus Load Parameters from the Drug Resource Enhancement against AIDS and Malnutrition Program

Background: The concept of universal antiretroviral use as a strategy for reduction of new cases of HIV infection has been evaluated in mathematical models as a potential approach to curtailing the Sub-Saharan African epidemic. In order to further substantiate such models, additional strategic parameters based on robust patient data should be considered, including survival of HIV-infected populations under HAART and subject infectivity as determined by HIV RNA levels. Methods: A retrospective cohort study was conducted in a population of patients enrolled in DREAMcenters throughout sub-Saharan Africa in order to determine survival under HAART. Cox regression analysis was performed evaluating parameters associated with survival such as CD4 cell count, viral load, body mass index (BMI) and hemoglobin (HB) levels. DREAM criteria for HAART initiation included (1) WHO stage 3-4 regardless of CD4 cell value (2) 100,000 copies in any subject. Virus load response to HAART was assessed in a subset of patients. Results: Adult non-pregnant patients who accessed DREAM centers from 1/2002 to 7/2009 were evaluated. A total of 34,295 patients (22,249 females/12,041 males) were included. Median age was 34 years (IQR:29-42) and median observation time 476 days (IQR:206 –950). Baseline median viral load, CD4 cell counts, HB and BMI values were 4.4 (IQR:3.6-5.0), 243 (IQR:109-416), 10.8 (IQR:9.2-12.4), and 20.3 (IQR:18.3-22.7).Over time 23,795 patients initiated HAART. Cox survival analysis (adjusted for Viral Load and HB) according to CD4 cell strata was performed. The relative risk of death in the lowest CD4 stratum (500) was 3.3 [2.7 –4.1]. Survival estimates at >7 years of HAART ranged from 50% to 95% according to baseline CD4 cell count and HB levels. In a subset of 13,405 subjects who received HAART for >6 months with at least 2 virus load measures available, 55.9% achieved < 50 copies/ml and an additional 19.7% achieved levels < 400 copies/ml (75.6% total). Final median virus load value was 58 (IQ: 0 –2000). Conclusions: Contrary to more conservative estimates used in mathematical modeling studies, patients in our cohort demonstrated a significant survival benefit even within the lowest CD4 cell stratum. Patients on HAART had low potential infectivity as measured by plasma virus load. Cohort data from African patients can contribute to the further refinement of predictive models

Measurement of viral load by the automated Abbott real-time HIV-1 assay using dried blood spots collected and processed in Malawi and Mozambique

Background. The use of dried blood spots (DBS) for HIV-1 viral load quantification can greatly improve access to viral monitoring for HIV-infected patients receiving treatment in resource-limited settings.Objectives. To evaluate and validate HIV viral load measurement from DBS in sub-Saharan Africa, with a reliable, all-automated, standard commercial assay such as the Abbott m2000.Methods. A total of 277 DBS were collected in different health centres in Malawi and Mozambique and analysed for viral load determination using the Abbott m2000 assay with the corresponding plasma samples as gold standard. Samples were extracted using the m2000SP automatic extractor and then processed as the plasma samples using the specific 1.0 mL HIV-RNA DBS protocol.Results. Among samples with detectable HIV-RNA the correlation between viral load obtained from the paired 131 plasma and DBS samples was high (r=0.946). Overall, viral load values between DBS and plasma differed by less than 0.5 log unit in 90.1% of cases and by less than 1 log unit in 100% of cases. Using a threshold of 1 000 copies/mL (defining virological failure in resource-limited settings), sensitivity was 94.2% and specificity 98.6%, and both positive and negative predictive values were high (98.5% and 94.5%, respectively).Conclusion. DBS extracted and processed using the Abbott automated system can be reliably used in resource-limited setting to diagnose virological failure

Evaluating adherence to highly active antiretroviral therapy with use of pill counts and viral load measurement in the drug resources enhancement against AIDS and malnutrition program in Mozambique

Background. Maintaining treatment adherence among the growing number of patients receiving antiretroviral treatment in Africa is a dramatic challenge. The objective of our study was to explore the results of a computerized pill count method and to test the validity, sensitivity, and specificity of this method with respect to viral load measurement in an African setting. Methods. We performed a prospective, observational study involving patients who received first-line highly active antiretroviral therapy in Mozambique from 1 April 2005 through 31 March 2006. Enrolled patients had received treatment for at least 3 months before the study. For defining treatment adherence levels, pill counts were used, and the results were analyzed with viral load measurements at the end of the observation period. Results. The study involved 531 participants. During the 12 months of observation, 137 patients left the program or discontinued first-line therapy. Of the remaining 394 patients, 284 (72.1%) had >95% treatment adherence; of those 284 patients, 274 (96.5%) had a final viral load <1000 copies/mL. A Cox proportional hazards analysis revealed that the relationship between >95% treatment adherence and the final viral load was closer than that between >90% treatment adherence and viral load. Conclusions. Treatment adherence >95% maximizes the results of the nonnucleoside reverse-transcriptase inhibitor-based regimen. The pill count method appears to be a reliable and economic tool for monitoring treatment adherence in resource-limited settings

Evaluating adherence to highly active antiretroviral therapy with use of pill counts and viral load measurement in the drug resources enhancement against AIDS and malnutrition program in Mozambique

Background. Maintaining treatment adherence among the growing number of patients receiving antiretroviral treatment in Africa is a dramatic challenge. The objective of our study was to explore the results of a computerized pill count method and to test the validity, sensitivity, and specificity of this method with respect to viral load measurement in an African setting. Methods. We performed a prospective, observational study involving patients who received first-line highly active antiretroviral therapy in Mozambique from 1 April 2005 through 31 March 2006. Enrolled patients had received treatment for at least 3 months before the study. For defining treatment adherence levels, pill counts were used, and the results were analyzed with viral load measurements at the end of the observation period. Results. The study involved 531 participants. During the 12 months of observation, 137 patients left the program or discontinued first-line therapy. Of the remaining 394 patients, 284 (72.1%) had >95% treatment adherence; of those 284 patients, 274 (96.5%) had a final viral load <1000 copies/mL. A Cox proportional hazards analysis revealed that the relationship between >95% treatment adherence and the final viral load was closer than that between >90% treatment adherence and viral load. Conclusions. Treatment adherence >95% maximizes the results of the nonnucleoside reverse-transcriptase inhibitor-based regimen. The pill count method appears to be a reliable and economic tool for monitoring treatment adherence in resource-limited settings

The DREAM model's effectiveness in health promotion of AIDS patients in Africa

This study evaluates the effectiveness of a holistic model for treating people living with AIDS in Africa; the model aims to improve knowledge about AIDS prevention and care, increase trust in the health centre, impact behaviour, and promote a high level of adherence to HAART. The study took place in the context of the DREAM (Drug Resource Enhancement against AIDS and Malnutrition) programme in Mozambique, designed by the Community of Sant'Egidio to treat HIV patients in Africa. It provides patients with free anti-retroviral drugs, laboratory tests (including viral load), home care and nutritional support. This is a prospective study involving 531 patients over a 12-month period. The patients, predominantly poor and with a low level of education, demonstrated a good level of knowledge about AIDS (more than 90% know how it is transmitted) and trust in the treatment, with a relatively small percentage turning to traditional healers. Overall the patients had a low level of engaging in risky sexual behaviour and a very good level of adherence to HAART (69.5% of the 531 subjects had a pill count higher than 95%). The positive results of the programme's educational initiatives were confirmed with the patients' good clinical results